ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UF

Basic Information

• Brand Name: ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UF
• Primary DI: 00850033615616
• Version / Model: 0P9BCFKNMR3EXT-U
• Catalog Number: 0P9BCFKNMR3EXT-U
• Company Name: THERMOTEK, INC.
• Labeler DUNS: 847899911
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-23
• Public Version: 1
• Public Version Date: 2026-03-03
• Public Version Status: New
• Public Device Record Key: 04bd48c5-77ac-4aeb-a7ae-432d229d668c

Device Description

ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UF

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	890.5720	2
JOW	Sleeve, Limb, Compressible	Cardiovascular	870.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40485	Circulating-fluid localized thermal therapy system pack, single-use	A device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a single-use device.	No	Active
44769	Single-chamber venous compression system garment, single-use	An inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the intermittent inflation of a single-chamber. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850033615616	GS1

Premarket Submissions

Submission Number	Supplement Number
K061866	000